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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . April 26th, 2006

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications

Carcinogenesis - Acrylamide and its metabolite glycidamide are genotoxic in mice

Polymerase Chain Reaction - PCR method to detect toxin genes in enterotoxigenic Escherichia coli has been developed

Salmonellosis - Drug-resistant Salmonella outbreak is linked to ground beef in U.S.

Salmonellosis - Sample preparation affects recovery of Salmonella from fruit

Acne - Reliant Technologies announces U.S. FDA clearance of the Fraxel Laser for acne and surgical scars

Adverse Drug Reaction - Fosphenytoin may cause hemodynamically unstable bradydysrhythmias

Allergy Medicine - Method to determine phenylephrine, chlorpheniramine, and methscopolamine is developed

Alzheimer Disease - Humanetics, Mount Sinai School to launch trial of new Alzheimer compound

Anthrax - Elusys Therapeutics completes human clinical study of the anthrax therapeutic Anthim

Anthrax Vaccine - N-fragment of edema factor is candidate antigen for anthrax vaccine

Anthrax Vaccine - Persistence of immunity following anthrax vaccination was examined

Anxiety - Pfizer's Lyrica approved for generalized anxiety disorder in Europe

Avian Influenza - Fort Dodge Animal Health announces licensure of a reverse genetics avian influenza vaccine

Avian Influenza - Survey shows striking gap between employer concern and current pandemic preparedness

Avian Influenza Vaccine - Adenovirus-based vaccine protects against lethal H5N1 avian influenza

Avian Influenza Vaccine - Antigen working with U.S. FDA to fast track flu vaccine

Avian Influenza Vaccine - Reverse-genetics is most rapid method to produce avian influenza vaccine

Awards - Signalife receives Technology Innovation Award for 2006 from Frost & Sullivan

Bacteriology - Researchers detail new studies and findings in the area of bacteriology

Behavioral Medicine - Responsive virtual human technology as interviewer training tool has been developed

Business & Finance - DOR BioPharma reports 2005 financial results, sees reduction in net loss

Business & Finance - Ophthalmic company InSite Vision reports Q4 2005 net loss of $4.1 million

Business Update - FDA advisory committee recommends against approval of SPARLON for ADHD in children, teens

Cancer Research - Epidemiology study shows no risk between aspartame and cancer

Cancer Vaccine - Multi-epitope peptide vaccines alter CD8+ T cell responses

Candidiasis - DNA probes for rapid identification of Candida species have been developed

Cardiovascular Disease - Corgenix files 510(K) for AtherOx, a predictive cardiovascular diagnostic line

Cardiovascular Disease - Therapeutic effects of xanthine oxidase inhibitors are considered in review

Chronic Obstructive Pulmonary Disease - GSK announces positive results of Seretide survival study in COPD patients

Clinical Trials - Cubist Pharmaceuticals submits response to FDA Approvable Letter on Cubicin

Clinical Trials - Encysive Pharmaceuticals delays studies with TBC3711

Clinical Trials - Exelixis initiates Phase II clinical program for XL784 in diabetic nephropathy

Clinical Trials - Flaws in Pfizer's antifungal trials of voriconazole are discussed in professional publication

Clinical Trials - Guidant to temporarily suspend XIENCE V supply, stops enrollment in SPIRIT III

Clinical Trials - Inspire to provide added information to U.S. FDA after meeting on dry eye program

Clinical Trials - Yale researchers find phenoxodiol restores sensitivity to chemotherapy in some cancer patients

Collaborations - Columbia U Medical Center uses Cyberkinetics' NeuroPort System to research brain activity

Colorectal Cancer - Colorectal cancer risk linked to serum C-reactive protein levels

Contraception - Effective use of combined oral contraceptive pills is focus of review

Contraception - Use of hormonal injectables and contraceptive implants is focus of review

Diabetes Control - DexCom receives FDA approval for STS Continuous Glucose Monitoring System

Diabetes Epidemiology - Amino acid variants in activating transcription factor 6 gene linked to type 2 diabetes

Diabetes Monitoring - FDA approval of continuous glucose sensor accelerates development of artificial pancreas

Diabetes Monitoring - FDA issues clearance for AgaMatrix's high-accuracy blood glucose monitor

Diabetes Therapy - Hospitals fail to record concurrent diabetes diagnoses during hospitalization

Diabetes Therapy - Takeda submits new drug application for extended-release type 2 diabetes medication, ACTOplus met

Drug Abuse - $3.3M available for prevention of methamphetamine abuse in U.S.

Drug Approvals - FDA approves extended dosing of Aranesp to treat chemotherapy-induced anemia

Drug Development - Aastrom Biosciences receives orphan drug designation for bone marrow cells

Drug Development - Accentia's partner receives U.S. FDA approval for new pain medication dosage

Drug Development - Adams initiates phase II program for Erdosteine

Drug Development - Adherex receives regulatory clearance for phase II weekly dosing schedule

Drug Development - Amgen, Abgenix complete BLA for U.S. FDA approval of panitumumab

Drug Development - Axcan submits U.S. FDA amendment to its new drug application for Helizide

Drug Development - CuraGen and TopoTarget announce initiation of first NCI-sponsored clinical trial with PXD101

Drug Development - FemmePharma Global Healthcare, Inc. opens IND application for treatment of breast pain

Drug Safety - Pfizer welcomes European Commission warning about counterfeit medicines putting patients at risk

Environmental Health - Method to determine N-methyl carbamate at low ppb levels in eggs is developed

Environmental Health - Method to measure phenols and chlorinated chemicals in breast milk is developed

Environmental Health - Pregnancy complications/birth defects related to nitrates in drinking water are focus of review

Environmental Health - Pregnancy-induced hypertension risk may be increased by higher environmental lead exposure

Enzymology - Vaccinia virus glycosylase forms heterodimeric processivity factor for viral DNA polymerase

Epidemiology - Influenza-related mortality of U.S. elderly varies by geographic region

Food Safety - Chromogenic plating medium to isolate Enterobacter sakazakii developed

Food Safety - Method to measure mercury in carbon black has been developed

Foot-and-Mouth Disease - Method detects cell-mediated immune responses to foot-and-mouth disease virus

Genetics & Genomics - Cardiovascular disease studied in Hutchinson-Gilford progeria syndrome transgenic mouse model

Gonorrhea - Gonorrhea aspects of importance to dentists are focus of review

HIV/AIDS Epidemiology - Researchers' findings advance HIV/AIDS epidemiology research

HIV/AIDS Pathogenesis - HIV Vif and Vpr play key roles in T cell death and cell cycle arrest

HIV/AIDS Testing - Calypte's Aware rapid HIV-1/2 tests receive approval in the Republic of Kenya

HIV/AIDS Therapy - HIV-infected newborns may need higher nelfinavir dose than FDA guidelines

HIV/AIDS Therapy - Integrase cofactor plays key role in HIV replication cycle

HIV/AIDS Therapy - U.S. FDA tentatively approves a co-package of generic AIDS drugs

HIV/AIDS Vaccines - Studies add new findings to HIV/AIDS vaccines body of knowledge

Heart Disease - Oral contraceptives increase stroke and heart attack risks in women with hypertension

Heart Failure - Nanogen receives U.S. FDA 510(k) clearance for StatusFirst congestive heart failure NT-proBNP Test

Hepatitis B Therapy - PowderMed's Therapeutic DNA vaccine for chronic hepatitis B enters phase I trials in patients

Hepatitis B Virus - Recombinant GB virus B hepatitis virus with a p7 protein developed

Hernia - Corgentech reports Phase 2 trial results in Europe for 4975 in hernia repair pain

Immunizations - Position paper on adolescent immunization has been released by Society for Adolescent Medicine

Immunology - HIV intrauterine exposure affects infants' cellular immune response

Influenza Vaccine - Inactivated influenza vaccine was not effective in children younger than 2

Influenza Vaccine - Influenza vaccination rates in British nursing homes vary widely

Influenza Vaccine - Universal influenza vaccine plus adjuvant provides complete protection

Influenza Vaccine - Virosomal influenza vaccine is effective in most HIV-infected children on HAART

Influenza Vaccines - Recent findings illuminate research in influenza vaccines

Information Technology - Maxant Technologies receives U.S. FDA clearance to market MediPort integrated digital workstations

Iron Deficiency - Ferrazone iron compound receives FDA acceptance

Listeriosis - Method for DNA probe detection of Listeria in culture is improved

Lung Cancer - Cytokinetics reports data for ispinesib in platinum-sensitive non-small cell lung cancer

Lyme Disease - Anti-IL-15 prevents arthritis in Borrelia-vaccinated and -infected mice

Lymphatic Filariasis - China to be officially designated free of lymphatic filariasis

Malaria Vaccine - Escheriosome-entrapped antigens protect against Plasmodium yoelii nigeriensis

Market Analysis - Dyslipidemia and other metabolic disorders are focus of latest offering

Marketing - Santarus announces U.S. launch of capsule form proton pump inhibitor for heartburn, GERD

Medical Devices - Analogic receives 510(k) U.S. FDA clearance for wide-beam fetal ultrasound transducer

Medical Devices - ArthroCare receives U.S. FDA clearance for vertebroplasty device

Medical Devices - BSD Medical applies for U.S. FDA approval of cancer treatment system

Medical Devices - Detectability decreases with off-normal viewing in liquid crystal displays

Medical Devices - MatrixOne and IntegWare enter alliance to deliver compliance solutions to medical device industry

Medical Devices - U.S. FDA approves Sorenson's release of ambulatory infusion pumps for pain management

Medical Errors - Method for automatic identification of confusable drug names is developed

Melioidosis Vaccine - DNA vaccine protects against Burkholderia pseudomallei infection

Meningitis Vaccine -  Haemophilus influenzae type b vaccination of children is focus of review

Mergers & Acquisitions - IRIS International acquires Leucadia, enters the molecular-diagnostics market

Muscular Dystrophy - PTC Therapeutics receives fast track designation for PTC124 for Duchenne muscular dystrophy

Mutagenesis - Mouse lymphoma thymidine kinase gene mutation assay is described

Myelodysplastic Syndromes - Pharmion Corporation submits Vidaza new drug application supplement for IV administration

Occupational Health - Lung disease risk is increased in workers at microwave popcorn plants

Ovarian Cancer - PABA/NO analogues with improved solubility and aqueous stability synthesized

Pelvic Inflammatory Disease - IUD increases risk of pelvic inflammatory disease among women with STD

Pigmented Lesions - Cynosure receives additional FDA clearance for pulse dye laser

Pneumococcal Vaccines - Reports advance knowledge in pneumococcal vaccines research

Polio Vaccine - No link was found between oral polio vaccine and intussusception

Polymerase Chain Reaction - DNA and RNA references for qRT-PCR assays in cervical cells are reported

Prion Disease - Data advance knowledge in prion disease research

Proteomics - Data advance knowledge in proteomics research

Restructuring - NitroMed restructures research and development operations to focus on extended release BiDil

SARS Vaccine - Inactivated Vero-cell SARS vaccine is safe and effective in monkeys

SARS Vaccine - SARS vaccine candidates were evaluated in mice challenged with SARS coronavirus

Sepsis - Masimo announces U.S. FDA clearance of Masimo Rainbow SET Rad-57cm

Sexual & Reproductive Health - New data indicate few young Americans tested for chlamydia

Sexual & Reproductive Health - Uterine leiomyomata may be increased in women with higher luteinizing hormone levels

Sexually Transmitted Disease - No clear link was found between hormonal contraceptives and STD risk

Smallpox Vaccines - New data illuminates research in smallpox vaccines

Smallpox Vaccines - Researchers provide details of new studies and findings in the area of smallpox vaccines

Thrombolysis - New anticoagulants are under development

Transplant Medicine - VCU medical center team implants first total artificial heart on East Coast

Trypanosomiasis Vaccine - DNA vaccine controls Trypanosoma cruzi infection

Tuberculosis Transmission - TB increase among young children caused by close family interaction and delayed diagnoses

Tuberculosis Vaccine - BCG substrains confer different levels of protection against Mycobacterium tuberculosis

Tuberculosis Vaccine - Dendritic cells infected with Mycobacterium tuberculosis mutants induce immunity

Tuberculosis Vaccine - Neonatal BCG immunization rate is low among white British children

Twin-to-Twin Transfusion Syndrome - U.S. FDA approves humanitarian device exemption for treatment of Twin-to-Twin Transfusion syndrome

Type 2 Diabetes - New drug application for Galvus as diabetes treatment accepted for review by U.S. FDA

Vaccine Vector - Adenoviral vector has limited toxicity after salivary gland delivery

Venous Thromboembolism - Hormonal contraceptive use by women with thrombogenic mutations is focus of review

Virology - Findings in virology provide new insights

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